IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

Summary

The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.

Timeline

Start

2018-11-19

Primary completion

2019-06-26

Completion

2019-07-24

Outcome

Missed primary endpoint

registry analysis (non-inferiority test); Omadacycline 200 iv/200 iv vs Levofloxacin 750 iv/750 po or iv; Treatment difference -2.6 (95% CI -12.4 to 6.9) NCT03757234 ↗

registry analysis (non-inferiority test); Omadacycline 200 iv/200 iv vs Levofloxacin 750 iv/750 po or iv; Treatment difference -5.4 (95% CI -23.6 to 12.7) NCT03757234 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Levofloxacin	Small molecule	750 mg	Intravenous
Subject	Omadacycline	Small molecule	100 mg	Intravenous
Subject	Omadacycline	Small molecule	200 mg	Intravenous
Subject	Omadacycline	Small molecule	300 mg	Intravenous
Subject	Omadacycline	Small molecule	450 mg	Intravenous

Indications